Trans-endoscopic balloon dilation of accessible gastrointestinal tract strictures offers the advantage of not requiring removal of the endoscope and insertion of a different device (frequently under fluoroscopic guidance) in order to accomplish dilation. Procedure durations are therefore minimized, patient and staff exposure to radiation is avoided, and, when the procedure is to be continued beyond the dilation, the necessity of repeating endoscopic insertion is eliminated. The later is particularly important in minimizing risk to the patient in those instances where initial passage of the endoscope to the location of the stricture is difficult.
Through the endoscope, balloon dilation of tight esophageal strictures is frequently carried out with fluoroscopic monitoring. A stricture is considered to be “tight” if an endoscope cannot be passed through it. Fluoroscopic monitoring of tight stricture dilation is believed to help prevent sudden fracture or splitting of the stricture and thus reduce the risk of esophageal perforation during the dilation procedure. Currently available dilation balloons are made of transparent material to facilitate visualization. U.S. Pat. No. 6,953,431 to Barthel, which is incorporated herein by reference, discloses an apparatus that enables direct observation of the stricture wall response during balloon dilation. This is an advantage unique to balloon dilation that is not possible with other dilation techniques.
Examination and accurate measurement of an esophageal stricture can only be accomplished visually or endosonographically if the endoscope can be passed completely through the stricture. Two techniques exist for accomplishing complete stricture passage with balloon dilation. The traditional method is to pass and inflate successively larger balloons across the stricture until a diameter of 15 to 40 mm is achieved. The last dilation balloon is then removed and the instrument is maneuvered through the stricture under direct unguided operator control. The post-dilation 15 or 40 mm diameter stricture lumen is 5 or 6 mm larger than the diameter of a standard video endoscope and 2 to 3 mm larger than the diameter of an echoendoscope. However, stricture elasticity, luminal tortuosity, and frequent shelving (stepped areas along the stricture) can prevent passage of the instrument, despite an apparently adequate dilation.
An alternative method for accomplishing complete stricture passage with balloon dilation is the “balloon-scope train method.” The stricture is dilated to a diameter 1 or 2 mm larger than the diameter of the endoscope. The endoscope is then pushed up against the proximal end of the inflated dilation balloon to form a balloon-scope “train.” The combination of balloon and endoscope is then advanced through the stricture.
Conventional trans-endoscopic balloon dilation systems, however, require a level of mechanical understanding and operational training that is seldom available among the individuals called upon to assemble and operate the devices during endoscopic procedures. More specifically, the components that must be collected and assembled include a shaft mounted balloon, an inflation gun, a manometer, and saline or other suitable fluid. The collection of these components and their assembly is required to render the currently available balloon dilation systems operational. The resulting procedural delays and device operation errors arising from improper assembly significantly mitigate the advantages of trans-endoscopic balloon dilation.
Thus, there is a need for a trans-endoscopic balloon dilation system that does not require intra-procedure assembly of components and the delays and errors that result therefrom. The needed device would be fully assembled in a factory and it would be pre-filled with a suitable fluid for balloon dilation. Such a device would enable an operating team to concentrate on the surgical procedure without the distraction of assembling a tool and the problems and delays associated with such assembly.